Evaluation of Serial Lung Ultrasound Data After Surfactant Treatments Applied With Different Methods in Preterm Babies

March 26, 2026 updated by: Melek Buyukeren, Konya City Hospital
This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the neonatal intensive care unit, lung ultrasound was first used for the diagnosis of neonatal respiratory distress syndrome (RDS) by Avni et al. in 1990. Following this, lung ultrasound rapidly became widespread in neonatal intensive care units and was seen as a potential alternative to chest X-rays. It is now frequently used in cases of RDS, transient tachypnea of the newborn, pneumonia, and pneumothorax. Lung ultrasound has high specificity, sensitivity, positive predictive value, and negative predictive value. It is performed quickly at the bedside, allowing for rapid diagnosis and timely intervention.

Respiratory distress syndrome is one of the most common causes of morbidity and mortality in preterm infants. It results from a surfactant deficiency in the lungs secondary to preterm birth. Early diagnosis and timely administration of intratracheal surfactant, which is the only definitive treatment, are crucial. The diagnosis has traditionally relied on chest X-rays, but with recent advancements, lung ultrasound has also become a diagnostic tool. In addition to diagnosing RDS, lung ultrasound plays a critical role in its differential diagnosis, severity classification, and management in neonates.

Different methods can be used for the intratracheal administration of surfactant in the treatment of neonatal respiratory distress syndrome. Surfactant can be administered through an endotracheal tube in intubated infants. In non-intubated infants, two commonly accepted and frequently used methods are available. The first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method). The second method involves delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method). Both of these methods are frequently used in neonatal intensive care units, and multiple studies comparing them indicate no clear superiority of one over the other.

Many studies utilizing lung ultrasound incorporate lung ultrasound scoring systems. The first neonatal lung ultrasound score was defined by Brat et al. Each lung is divided into three regions (upper anterior, lower anterior, and lateral), and each region is assigned a score from 0 to 3:

0 points: Defined by the presence of only A-lines.

  1. point: Defined by the presence of three or more well-spaced B-lines.
  2. points: Defined by the presence of multiple coalescing B-lines, with or without small subpleural consolidations.
  3. points: Defined by the presence of large consolidation areas. The total score, obtained by summing the scores from all lung regions, represents the infant's overall lung ultrasound score. Scores range from 0 (completely normal) to 18.

Based on existing lung ultrasound studies, this study will evaluate preterm infants born before 32 weeks gestation who are diagnosed with RDS. Serial lung ultrasounds will be performed at different time points following surfactant administration (5 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours after completion of surfactant administration), and lung ultrasound scores will be calculated. The aim is to determine whether different surfactant administration methods result in different lung ultrasound scores over time.

This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

The investigators plan to conduct their study at Konya City Hospital between July 2024 and July 2025. Preterm infants born at their hospital at or below 32 weeks of gestation, diagnosed with RDS, and requiring surfactant therapy without intubation will be included in the study. The families of the infants planned for inclusion will be informed about the study, and written consent will be obtained if they agree to participate. Only infants whose families provide consent will be included. The follow-up process and treatments of the included infants will not be altered in any way. The method of surfactant administration will be determined by the attending neonatologist. The physician performing the ultrasound evaluations and the principal investigator will be blinded to the method of surfactant administration. The choice of surfactant administration method will be made solely by the responsible physician.

A total of seven serial lung ultrasound evaluations will be performed at 5 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours after the completion of surfactant administration. Lung ultrasound scoring will be applied (each lung is divided into three regions: upper anterior, lower anterior, and lateral. Each region is assigned a score from 0 to 3: 0 points indicate the presence of only A-lines; 1 point indicates the presence of ≥3 well-spaced B-lines; 2 points indicate multiple coalescent B-lines, with or without subpleural consolidations; and 3 points indicate large consolidation areas). All ultrasound evaluations throughout the study will be performed by the same physician.

The demographic and clinical characteristics of the patients, as well as prenatal/postnatal risk factors, will be recorded in the patient data collection form. Additionally, ultrasound scoring results, oxygen requirements, and saturation values will be documented.

No invasive procedures will be performed on the patients, and no blood samples will be collected for the study.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants of families who agree to participate in the study
  • Preterm infants born before 32 weeks of gestation requiring surfactant therapy due to an RDS diagnosis.

Exclusion Criteria:

  • Infants whose families did not provide consent
  • Infants with a syndromic appearance or congenital heart disease
  • Preterm infants born after 32 weeks of gestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ensure group
The first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method).
Diagnostic test: Evaluation of serial lung ultrasound data after ENSURE surfactant treatments
Intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method)
Experimental: Lisa group
The second method involves delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method).
Diagnostic test: Evaluation of serial lung ultrasound data after LISA surfactant treatments
Delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of serial lung ultrasound data after surfactant treatments
Time Frame: 6 hours after completion of surfactant administration
This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.
6 hours after completion of surfactant administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Investigators

  • Principal Investigator: MELEK BUYUKEREN, Konya City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH_MB_2025_3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Once the study is published as a scientific article, it can be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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